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The regulatory precedent of pesticides

April 3, 2003

PFCs: Global Contaminants: The regulatory precedent of pesticides

April 2003

At first blush these statutory changes appear a radical departure from current policies, but in fact, the chemical industry already complies with these standards for pesticide products, proof that the industry can meet the same safety standards with commercial chemicals.

Pesticides in food are regulated under section 408 of the Food Drug and Cosmetic Act, which requires chemical companies to show that there is a “reasonable certainty of no harm” from exposure to a pesticide, for all exposed individuals, including explicit consideration of the fetus, infant and small child. This standard, which is well defined in case law and regulations, applies to all uses and all routes of exposure to a pesticide (food, air, and water considered together). “Reasonable certainty of no harm” is protective of the public health, particularly where the finding is contingent on fetal and infant exposure, but is not so protective that it cannot be met, or that companies can argue that it is onerous.

Section 408 also requires that pesticides with common mechanisms of toxicity be added together when assessing compliance with the reasonable certainty of no harm standard. This means that groups of pesticides, for example, all organophosphates, are added together when measuring compliance. In contrast, TSCA does not require that regulators assess the additive risks. Many major chemical classes commonly used in consumer products are characterized by common mechanisms of toxicity - phthalates, perfluorinated chemicals, and polybrominated diphenyl ethers, for example - and none are assessed in aggregate by EPA.

When data are not available, legal exposures for infants and children are required to be 10 times lower than for adults, and economic benefits are not allowed as an escape valve, or a means to permit higher risk.

To ensure that these tough standards can be met, the other governing statute, FIFRA (the Federal Insecticide Fungicide and Rodenticide Act), grants the EPA administrator broad (virtually unlimited) authority to request data, and to suspend the sale of the product when data are not generated (section 3, particular 3(c)2(B), and section 6). This is the key reform.

The legislative history of FIFRA is instructive. Beginning in the early 1980’s a series of congressional committee investigations and GAO reports documented that basic health studies had not been conducted for most pesticides on the market at that time. In response, Congress amended FIFRA in 1988 to require that all pesticides be “reregistered,”which meant that they had to be tested by contemporary standards and re-evaluated for their health risks.

This forced the EPA to deal with the same problem that they face today when considering a comprehensive testing program for toxic chemicals: what to do with all the chemicals already on the market?

EPA’s response, which largely was successful, albeit slow, was to impose strict timelines for testing and re-evaluation while granting EPA clear authority to require any test for any pesticide, and the authority to suspend the sale of a pesticide if the manufacturer refuses to do the test or fails to submit it on time. Compare this with TSCA where EPA must go through a rulemaking just to get one test on one chemical.

As a result of these amendments, EPA now requires about 120 tests for pesticide registration. These tests range from acute and chronic toxicity, to metabolism, environmental fate and residue chemistry. These tests include toxicity tests that will support regulatory decision making, not the superficial screening tests being conducted under the HPV testing program. EPA has reevaluated nearly all pesticides of any significance, starting in the early 1990’s with more than 100 pesticide active ingredients in about 20,000 different products applied to food crops. There is no reason that these same test requirements could not be applied in a tiered fashion to commercial chemicals regulated under TSCA.

Testing requirements alone have driven many compounds from the market. One good example is methoxychlor, a DDT relative, which was banned with little fanfare in 1999 when the manufacturer simply refused to conduct required health studies. Another good example is pesticides used in aircraft cabins. In 1995 EPA asked all manufacturers of pesticides applied inside commercial airplanes to do the exposure studies needed to show the use was safe. Not a single manufacturer of more than 200 products was willing to do the tests (because they knew that the use was not safe), and all uses of pesticides inside aircraft were unceremoniously banned in the United States in 1998.

Another great example of the power of FIFRA’s data generation authority involves the toxic byproducts of chlorinating tap water. The Safe Drinking Water Act does not give the EPA authority to require toxicity tests for drinking water contaminants. As a result, the agency is forced to negotiate test programs with polluters or the affected industry, or to pay for the testing from their own research funds. But because chlorine is a pesticide (it kills microbes in water), EPA was able to use the data call-in authority of FIFRA to require the chlorine industry to do a broad range of toxicity tests on chlorination byproducts that they otherwise had not planned to do.